Medical Device Regulations

Published on 14-03-2017

On Thursday 23 February 2017, the European Council released the final texts of its Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). The finalization of the legislative texts was shortly followed by a vote of the European Council to adopt the legislation on 7 March 2017. In April, the European Parliament will give its final vote. If passed, the Regulations can formally be published by May 2017.

With the Medical Device Directive (MDD) and In Vitro Diagnostics Directive (IVDD) dating back more than two decades, the new Regulations were long-awaited for. The rapid development of hybrid technologies and procedures for resolving disputes made the Directives obsolete much earlier than anticipated. Unfortunately, this became very clear after the 2010 PIP breast implant scandal, kick-starting the renewal of the Directives. The first proposals for the MDR and IVDR were submitted in September 2012, but the European Commission, the European Parliament and the European Council could not agree on the final document. A trilogue between the parties resulted in a compromise in June 2016.
Between June 2016 and now, not much has changed in the MDR and IVDR texts. Focusing on coherence and equivalence in all 24 official EU languages, the documents did undergo a legal-linguistic review to accomplish this. When the legislation is adopted by the European Parliament in April, there will follow a three year and five year transition phase for respectively the MDR and IVDR to reach full implementation. For MRD, late 2019 or early 2020 is expected; for IVDR late 2021 or early 2022. For the full MDR and IVDR texts, click here.